Magnetic Stimulation for Stress Urinary Incontinence

Overseen By Razia Sultana, MD, PhD

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Sunnybrook Health Sciences Centre

Disqualifiers: Pregnancy, Urgency UI, Chemo, others

Compensation: Varies

Number of Visits: 9

Duration: 3 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether magnetic stimulation, a non-invasive therapy, can help women with stress urinary incontinence, a condition where urine leaks during activities like coughing or exercising. Participants will receive either a real treatment or a sham (fake) treatment to determine any difference in results. Women who have experienced stress urinary incontinence for at least three months and notice urine leakage when they cough or strain might be suitable candidates. The goal is to determine if this non-invasive treatment can effectively strengthen pelvic muscles and reduce urine leakage. As an unphased trial, this study offers participants the opportunity to contribute to innovative research that could lead to new treatment options.

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications. However, you cannot have any concurrent or new planned treatment for stress urinary incontinence during the treatment period and the 3 months following it.

What prior data suggests that magnetic stimulation is safe for stress urinary incontinence?

Research has shown that magnetic stimulation is generally safe for treating stress urinary incontinence. One study examined possible side effects and found that patients usually tolerate this treatment well, with most reporting only mild discomfort, if any, during sessions. Another study assessed the safety of combining magnetic stimulation with mirabegron, a medication already used for other bladder issues. The results indicated that this combination was safe, with no major side effects reported. Overall, magnetic stimulation appears to be a low-risk option for managing stress urinary incontinence. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about magnetic stimulation for stress urinary incontinence because it offers a non-invasive solution that might provide relief without the need for surgery or medication. Unlike standard treatments like pelvic floor exercises or medications, this approach uses magnetic fields to stimulate pelvic floor muscles, potentially enhancing muscle strength and control more directly. Additionally, the treatment is administered while participants remain fully clothed and involves a simple, sit-down therapy session, making it a convenient option for many patients.

What evidence suggests that magnetic stimulation is effective for stress urinary incontinence?

This trial will compare magnetic stimulation therapy with sham therapy for stress urinary incontinence (SUI) in women. Studies have shown that magnetic stimulation effectively treats SUI by strengthening pelvic floor muscles, reducing urine leaks. A review of several studies found that this treatment significantly improves symptoms in people with urinary incontinence. Another study reported noticeable improvements in patients, such as fewer leaks. While the results are promising, researchers continue to explore the best ways to use this therapy for optimal results. ^{5 6 7 8 9}

Who Is on the Research Team?

P Lee, MD

Principal Investigator

Sunnybrook Health Sciences Centre,, University of Toronto

Are You a Good Fit for This Trial?

This trial is for adult females with stress urinary incontinence, who are not pregnant or planning pregnancy, without metal implants from umbilicus to knees. Participants should have no recent pelvic treatments and be able to follow the study protocol. Exclusions include those on current chemo/radiotherapy, with systemic diseases affecting bladder function, or other types of urinary incontinence.

Inclusion Criteria

I am not planning any treatment for stress urinary incontinence soon.

I am not pregnant and do not plan to become pregnant during the study.

I can empty my bladder well and have minimal pelvic organ drop.

Exclusion Criteria

My pad weight increase is less than 3 grams in a 24-hour test.

I am currently being treated for chronic pelvic pain.

You have metal in your body from the waist to the knees, or a heart pacemaker.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either magnetic stimulation therapy or sham therapy for stress urinary incontinence

3 weeks

6 visits (in-person)

Open-label extension

Sham treatment arm participants who do not meet treatment success may receive open-label magnetic stimulation therapy

3 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

24 months

Regular follow-up visits at 3, 6, 12, and 24 months

What Are the Treatments Tested in This Trial?

Interventions

• Magnetic Stimulation
• Sham Magnetic Stimulation

Trial Overview The trial tests if electromagnetic stimulation can help women with stress urinary incontinence by strengthening their pelvic floor muscles. It compares real magnetic stimulation treatment against a sham (fake) procedure to see if there's an actual benefit.

How Is the Trial Designed?

Group I: Magnetic stimulation therapy Active Control 1 Intervention

Participants will sit fully clothed on the magnetic stimulator chair, with knees apart at about the width of their shoulders, feet flat on the floor. The stimulator will be activated and the intensity gradually increased as tolerated by the participant up to an intensity of 100%. There are a total of 6 treatment sessions (twice per week) over 3 weeks.

Group II: Sham therapy Placebo Group 1 Intervention

Participants will sit fully clothed on the magnetic stimulator chair, with knees apart at about the width of their shoulders, feet flat on the floor. The stimulator will be activated and the intensity gradually increased as tolerated by the participant up to an intensity of 5%. There are a total of 6 treatment sessions (twice per week) over 3 weeks.

Who Is Running the Clinical Trial?

Sunnybrook Health Sciences Centre

Lead Sponsor

Trials

693

Recruited

1,569,000+

Innovation Fund of the Alternative Funding Plan from the Academic Health Sciences Centres of Ontario

Collaborator

Trials

2

Recruited

220+

Published Research Related to This Trial

In a study of 25 patients with stress urinary incontinence, flat magnetic stimulation significantly improved objective measures of continence, which remained effective even at a 3-month follow-up.

However, subjective quality of life scores returned to baseline levels three months after treatment, suggesting that additional treatment cycles may be necessary to maintain benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Flat Magnetic Stimulation for Stress Urinary Incontinence: A 3-Month Follow-Up Study. Barba, M., Cola, A., Rezzan, G., et al.[2023]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8283222/

Efficacy of magnetic stimulation for female stress urinary ... We found that MS treatment for SUI has positive outcomes, however, future studies should aim at establishing the best protocol for optimizing the therapeutic ...

2. nature.com nature.com/articles/s41598-019-45330-9

An Effective Meta-analysis of Magnetic Stimulation Therapy ... Our meta-analysis preliminarily indicates that MS treatment is an effective therapeutic modality for patients with UI.

3. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1002/nau.70082?af=R

Effectiveness of Extracorporeal Magnetic Stimulation in the ... This study's results also suggest that MS only shows statistically significant improvements in the International Consultation on Incontinence ...

4. mdpi.com mdpi.com/2077-0383/10/21/5210

Effectiveness of Magnetic Stimulation in the Treatment ... This paper focuses on the effectiveness of magnetic stimulation (MS) in the treatment of UI. We performed a systematic review in order to combine and compare ...

5. journals.lww.com journals.lww.com/md-journal/fulltext/2019/05100/magnetic_stimulation_for_female_patients_with.82.aspx

Magnetic stimulation for female patients with stress urinary ... To evaluate the efficacy of MS, the primary outcomes of interest were considered as urine loss on pad test per day, number of leaks in a 3-day voiding diary, ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10383588/

Evaluation of Possible Side Effects in the Treatment of Urinary ... Magnetic stimulation is a type of conservative treatment of urinary incontinence. Our aim was to evaluate the possible side effects of this method.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10298542/

Flat Magnetic Stimulation for Stress Urinary Incontinence According to questionnaire results, there was an improvement in urge and stress urinary incontinence symptoms at the baseline and after ...

8. trialsjournal.biomedcentral.com trialsjournal.biomedcentral.com/articles/10.1186/s13063-015-0803-1

Magnetic stimulation for stress urinary incontinence - Trials The primary outcome is the improvement in severity of involuntary urine loss based on the International Consultation on Incontinence ...

9. frontiersin.org frontiersin.org/journals/neuroscience/articles/10.3389/fnins.2024.1373375/full

Efficacy and safety of pelvic floor magnetic stimulation ... Objective: To observe the efficacy and safety of pelvic floor magnetic stimulation (PFMS) combined with mirabegron in female patients with ...